2025 Australia-UK Platform Studies in Areas of Unmet Clinical Need Grant Opportunity 19 November 2024 – Video

Gill Beckett started transcription

Sarah Puddicombe   0:07
And we can get someone.
In the secretariat to help you out.
So really warm.
Welcome to our webinar about our 2025 Australia UK platform studies in areas of unmet clinical need.
It's it's early in the morning for those of you in the UK and apologies to those of you in Australia for for the lateness of of the webinar for you.
It's quite tricky to find a time that works for all but a really warm welcome to you all.
And we're going to run through the agenda.
Just done a little bit of housekeeping.
As I said, we at the beginning we are recording this and we will make the recording and FAQ available to you.
I'll be introducing the presenters and then we'll give you some background to this call, will talk through the scope of the funding opportunity.
What the eligibility criteria are some of the key requirements that you'll need to consider as applicants and the assessment criteria that will be used when when the committee are reviewing your application, your application.
We then run through an overview of the application timeline and assessment process and some additional checks that we required by Australia when funding recommendations have been made.
We'll pointing you to some national support for UK and Australian leads when writing your applications, and then we'll we'll run through some hints and tips on what to look out for and what to consider in a in an application that you're preparing and then we'll end up with.
In a session.
So we have presenters to Dave, Vanessa Thompson from the UK Department of Health, Anika Prabhu, who's from the medical Research future fund.
Andrew Farmer, our Nhr health technology assessment programme director and myself, Sarah Puddicum. I'm the assistant director for research programs responsible for global health and international. So a really warm welcome to you from our presenters.
We'll then have AQ and a panel session at the end.
Well, I'll introduce more colleagues. So we'll have Chris Jennaway, who's from the the medical research, sorry, the National Health and Medical Research Council in Australia.
Cherry Atkinson from the medical Research future fund, Michelle Bailey as well from the MRFF, John Simpson who is our program director for the MRC.
NHL efficacy mechanism and evaluation program.
A consultant advisor, Andrew Cook, to answer particular questions around applicants, and we have seen research managers Lisa Douay, Debbie Willis, Gemma Bashavoy and Charlotte Minter, who are also here, to be able to ask more technical questions around your applications that you may have.
So moving swiftly onwards, I'm going to move towards the background.
Call and invite Anika Prabhu to to introduce the first slides, followed by Anessa Thompson. Anika over to you.

PRABHU, Anika   3:38
Thank you, Sarah.
So I'd just like to start by showing my respects and acknowledging the traditional custodians of the land that I'm joining from.
For me, that's the nonawall country and extend that respect to elders, past and present, and any First Nations people that may be joining us today.
I just want to say that I'm so pleased that we've been able to launch this joint call between our two countries and also between the three funding bodies, this partnership and grant opportunity was really built on discussions between Australia and the UK.
The 2022 World Health Assembly, where a new resolution resolution was adopted to strengthen the global clinical trials ecosystem so that resolution drew on lessons from the COVID-19 pandemic and included a recommendation for funding bodies to promote cross country collaborations.
So this grant opportunity, the 2025 Australia UK platform studies in areas of unmet clinical need.
Grant opportunity supports the development of adaptive.
Home trials. So during the pandemic, these types of trials were able to rapidly add new therapies and deliver results demonstrating their potential in a non pandemic context as well.
So our teams recognize the challenges that are faced by clinical trials and that collaborative international trials could deliver a whole range of benefits.
So some of these benefits include greater access to patients and faster recruitment.
A.
Broader diversity of patients and health systems.
Access to greater medical expertise and clinical research infrastructure, including clinical research networks.
High methodological standard and broader implementation of results and the use of common tools, standards and procedures to allow efficiencies including cost efficiencies through the collaboration.
So this grant opportunity is currently open and I just wanted to emphasize up top that all applications.
All UK and Australian applicants will need to submit.
Through the NIH Rs realm system by that deadline that's on the screen there for stage 123rd of July 2025.
So with that, I'll hand over to Inessa.

Thomsen, Inesa   5:56
Hi, good morning, good evening everyone.
What a pleasure to be here today.
So the NRA chair has a long standing collaboration with NHMRC focusing on phase three clinical trials through the NHA Health Technology Assessment program and over 10 years, NHMRC have jointly commissioned 16 awards funding research in the UK and Australia on important research questions for the barefit of both.
UK and Australian populations, we are delighted to be joined.
Joined by MRFF as we embark on the next step in our UK, Australia Clin health research.
As have research funders with fully recognized importance of international clinical trials and are committed to continuing to support these through both joint funding but also through streamlining and harmonising our assessment processes, as well as funding joint research studies, we are keen to facilitate knowledge exchange and building rese.
Capacity and clinical trials between our two countries, fostering the future generation of clinical trials leaders.
Next slide please.
The joint call between MRFF, the NHMRC and NHR will support funding for new collaborative research to establish platform studies in areas of unmet clinical need in Australia and the UK, with a joined single funding assessment and coordinated financial approvals, we aim to facilitate and support new collaboration for.
Joint Australia UK platform trials.
The Australian based components will be funded through MRFF or NHMRC.
And the UK based components will be funded through the NRI in the UK.
Never back to you, Sir.

Sarah Puddicombe   7:45
Thank you.
I'm going to hand over now to Andrew Farmer, who's going to run through some of the scope of this funding opportunity.
Over to you, Angie. Thank you.

Andrew Farmer   7:58
Thanks very much, Sarah, and likewise really great to be here to help introduce this opportunity.
So I'm going to walk through the scope of this current funding opportunity.
Platform based approaches to developing research in key health areas and as an esser is very nicely sort of pointed out. This is builds on a long standing collaboration which has produced some really.
Interesting and impressive and impactful work.
So very much looking forward to this, this great sort of development of that.
So as you've heard, this is about areas.
Of unmet need based on strategic interest.
So there needs to be potential for impact of these interventions.
Specifically looking at childhood brain and prostate cancers, stroke and traumatic brain injuries, neurodegenerative diseases.
And cardio metabolic diseases like obesity.
It's not limited to those, but whichever area you choose to apply when it's got to have potential for a platform approach, and I guess I think.
The next slide gives.
We'll sort of try to sort of flesh out what we mean by platform.
And why it's important to be doing that.
From from our point of view, we think that platform trials.
Are multi arm studies that use a master protocol and a shared infrastructure to evaluate multiple interventions at the same time?
So.
Obviously there's a real strength of platforms that it allows for flexibility.
Arms can be terminated early if interim analysis indicate no benefit.
New arms can be added as promising new interventions emerge.
And this adaptability is particularly useful in areas where multiple technologies are in development, allowing researchers to pivot towards the most promising interventions as data accumulates.
So to get efficiencies, it really is important to be looking at similar groups of patients or the same groups of patients and the same ways of developing interventions or delivering interventions and measuring the same or related outcomes.
We've had experience in both the the Health Technology Assessment Program here funding program here and the EMI program which John represents in terms of funding these trials and some applications sort of.
It's really not apparent why one would do it.
Well, why one would use a platform? It's sort of, you know, just a series of large trials.
So we're looking for something that really does represent.
A way to to cohere not just for.
Because it might deliver at low cost.
Because often you know these these trials don't.
But there's something about the operational efficiencies and the efficiencies of delivering the trial and delivering the trial in a simple way.
So we I think we've got one more slide.
Is that right?
Or two more slides.
Yeah. So we're looking either for phase two or phase three focus slides focused.
Platforms. So either for phase two, there's a convincing evidence of a promising pipeline of technologies justifying.
A platform approach or.
The OR a platform or a phase three study which where there is.
Evidence of.
Efficacy and.
Certainly.
Multiple interventions in a defined group of people or circumstances.
We are not going to provide, at least on this occasion, funding or support platforms which which have a transition from phase two to phase three in them.
I think we will obviously be flexible in looking at whether it is phase two or Phase 33, but.
The types of funding and the types of infrastructure we think may be very different for for doing those.
So at the moment, we're not planning on doing that.
We are expecting these platforms to not only sort of propose that the proposed interventions or the candidate things for candidate interventions, but also.
To lay out the pipeline of promising future candidates.
So it's really important not to be thinking and showing that this worth doing this because there is a pipeline of promising interventions.
Coming, coming along, that's going to sustain it.
However, we are clear that that funding for those further technologies for those further interventions would need to be secured from other sources to support future sustainability.
Really important that these platforms become established and have a life of their own.
What more slide I think.
No, that's great.
So thanks very much for the opportunity to speak. Thank you.

Sarah Puddicombe   13:49
Thank you very much, Angie.
We're now going to move on to talking about the eligibility and the key sort of requirements that you need to consider.
So this opportunity is really about describing a new platform study as Andrew mentioned, and you have to be seeking to evaluate a number of specified technologies.
I won't go into it again, but again, you know, we want either a phase two or a phase three approach.
We encourage you to also think about building in a public and patient involvement and thinking about opportunities to provide experiencing capacity building amongst early and mid career researchers. And as Andrew mentioned again thinking about that sustainability of the platform beyond that initially funded work.
We're looking for your proposed studies to be multi centre and collaborative and your recruitment.
Must be split across both the UK and Australia, but it doesn't necessarily have to be equally split.
We do expect, however, to see a minimum of about 20% recruitment in anyone country.
If you're thinking about international recruitment in other countries beyond the UK and Australia, I'm afraid that we as funders are unable to support those, and you will have to seek other alternative funding sources to pay for the recruitment costs in other countries.
Please do make sure that you've read the eligibility requirements that we set out.
We're trying to run through them today, but there is much more detail in in our sort of documents online and I will refer you particularly for Australian based applicants to look at the MRFF and the NHMRC grant opportunity guidelines. And if you have specific questions around the austral.
Elements then.
Our Australian colleagues can obviously answer those today and we'll work closely with them to to help support you.
OK. Applicants, please look at our NHL funding opportunity guidance.
In terms of the research team, we're looking for applications to be jointly led so that you will have AUK and an Australian lead and for the UK application only we do require you to have the named UK chief investigator and for the Australian lead to be named as.
A Co applicant so that we can just track the involvement across the the proposals.
Do you think about how you can have a strategy to allow collaborators to join and exit the platform over time and to think about publication plans that might enable the recognition of collaborative collaborators, contributions and thinking about some of that succession planning to allow leadership of the plat?
Perhaps to change over time as it becomes sustained.
We're particularly interested in ensuring that you have capacity building amongst early and mid career researchers.
We're not, unfortunately expecting those to be leads or a sort of chief investigators on these awards, but we are hoping that you can think about building in opportunities for them to gain experience and training in the conduct and leadership of clinical trials.
So then do you think about the costs for including those those?
Early career mid career researcher opportunities and for their sort of exchanges and anyone who is actually then funded through our awards will then become members of the Nhr Academy and we've got Charlotte with us today who can answer questions about that later. But essentially you will have access.
Then to our online career development events and training and support.
Resources for anyone who is supported through your award. We do encourage you strongly to think about having a named point of contact for training and development, and to put that name into the application please. And to think about training and support, which is in line with the Princip.
And best practice set out in the research and development concordat.
We are looking for in a diverse range of career pathways as well and disciplines, so we encourage you to think about that.
So that we can help ensure that future skills are developed in in relation to clinical trials.
The eligibility for early mid career researchers are for the early career. Those who are within five years of their PhD award date or an equivalent for clinicians and practitioners.
For mid career researchers, we're looking at those between 5 and 10 years of their PhD award date.
And obviously, we accept career disruptions or equivalent time spent on non research activity within those those date ranges.
Please ensure that anyone who is proposed will have been awarded their PhD or their MD by the time the award is due to start.
And each of those posts should be competitively awarded.
Include a training plan and have a defined end point and to be determined as a as an nhr Academy member. Those early career researchers should have at least 25% of their funding through your award.
As I mentioned earlier, I'm afraid for this particular call, we're not able to support early career researchers as a named joint chief investigator. So Please ensure that you have another person in your team who will fulfil that role.
Over to you, Annika.

PRABHU, Anika   19:50
So the total amount of funding available for this call is equal to 30 million Australian dollars or £15.5 million. And so with this amount we expect to be able to fund one to three platform trials for up to seven years and keep in mind that.
Value for money is a key consideration in the assessment process. So for the Australian component, the maximum grant amount that can be requested is 5 million austral.
$1,000,000 over up to seven years.
And so with that, the NIHR amount will be approximately £2.3 million awarded per grant over that seven years.
The NIHR will only be funding the UK research components and then the NHMRC or MRFF will only be funding the Australian Research components and there won't be any split funding arrangements between the NHMRC or MRFF.
Up to 10% of the awarded funding can be used overseas, so in countries.
Not Austria, that are not Australia or the UK.
This is only in specific situations, so not for patient recruitment as Sarah has mentioned, but it might be for specific coordination purposes or where it's justifiable that the support is not available in either Australia or the UK. So please read the guidance carefully for that information. Next slide.
Please.
So what is not eligible for this grant opportunity?
So existing platforms are not eligible for further funding under this call.
Any applications that don't involve an Australian and UK collaborations are not eligible.
Keep in mind that chief investigators or CIS can't be named on more than one application to this call and any applications that significantly replicate trials that have been funded by any of the funding bodies aren't eligible. So.
So again, carefully read the NIHR funding opportunity guidance on the NIHR website as well as the Australian Grant Opportunity guidelines which are available on Australia's Grant Connect website. For full details of the eligibility criteria and any other restrictions.
Thanks. Back to you, Sarah.

Sarah Puddicombe   22:09
Thank you.
So we're now going to touch on the assessment criteria that the committee will use when they're reviewing your applications.
So in terms of writing your bid, please do make sure that your proposal really does match the call specification that we've put out.
Think about the scientific rigour and make sure that the study design really is going to answer the research question that you're proposing.
And that that study will be feasible and deliverable.
The committee will be looking for value for money.
So think about the proposed cost of the research.
Make sure that they're reasonable and commensurate with the work that you're proposing.
And think about the cost to the health and care services in supporting the research so that they're reasonable and likely to sort of bring benefits of the research to decision makers, patients and the public.
We would like to, as I mentioned earlier, you think about that experience of the research team making sure that they are able to deliver multi centre interventional studies across the UK and Australia and that there's sufficient experience of innovative adaptive designs particularly platform studies which is completely rele.
To this call.
In terms of.
Public and patient involvement, we would really like to see a very strong demonstration of this within your proposal and evidence of a prior track record of working with members of the public and people who either draw on services or in locations of greatest need and how you person.
Have taken these needs and priorities and views and their values into account when designing the research plans and and you've embedded that in.
Across the research.
Life cycle so that that's really very firmly involved that those views are firmly involved and have really informed not only the research but also some of the plans for dissemination as well.
In terms of research inclusion, that's very much a strong thread through both Australia and the UK and we really would like you to think about how you can start to target underserved populations and demonstrate how outcomes will really benefit those populations and contribute to their improved health out.
We're obviously looking for you to be thinking about working very closely in partnership with local healthcare organisations.
And other international collaborations and we and we're also keen to think about where relevant you thinking about engaging very closely with industry particularly for those interventions perhaps drug or devices that might require more of that involvement.
Now we we encourage industry involvement from anything from sort of interventions being provided, such a free of charge or at a discount to other in kind.
Contributions to potentially arms of studies being funded by industry where relevant.
We do encourage you though to ensure that you're upfront with industry partners and share both our grant and contract terms with those partners. So they're very clear about the arrangements on data sharing and the IP ownership.
And that's really clear up front.
So we have examples of our contracts and we can be circulating those.
Through our guidance notes as well.
Please also think about establishing and coordinating that data from across all of your sites particularly.
For these trials, because I think those are going to be a particular area of interest in, in terms of these trials.
So we're now going to talk a little bit about the application and assessment process.
So this is a two stage call.
The first stage is has opened now in in October.
We've got our webinar today and the deadline for that stage 1 application will be on the 23rd of July 2025.
We've given a decent length of time for you to be able to meet up to develop your collaborations and to put in a bid.
You will have to apply on our Nhr realm system as Annika mentioned, and all of the recordings and FAQ from today will be published and made available to you.
Once you've submitted applications, undergo a remit check where we as funders, will ensure that you've met the eligibility criteria you're in, in remit of the call, and we will invite some details.
From the Australian collaborators to help us assist in undertaking conflict checks.
We'll have a joint funding committee comprising of UK and Australian Committee members and they will assess all of those stage 1 applications.
And we'll provide feedback to everyone whether they're successful or not. At stage 1, the stage 1 outcomes will be notified in October of this year.
Sorry. Next year, 2025 and we will then open up our system to invite stage two applications from those who were successfully shortlisted.
Stage two process will then run from October 25 to November 2025, when the stage two deadline.
Submission will be required.
That will be at 10 O clock UK time and 90 clock in Australian time.
We will then undergo peer review with all of the applications having independent expert review.
Those peer review comments will be shared with applicants.
There'll be an opportunity for applicants to provide rebuttals, and those rebuttals will be combined with the application and shared with the committee for their consideration. The committee will meet in February of 2026, and we hope that the awards will start no later than Q2 or.
Q3 of 2026, but you'll you'll find out in the outcome of the the decisions and around Q2 of 2026.
I'm going to then move over to Anika, who's then going to explain.
What what will happen in terms of the recommended?
Applications and the Australian review.

PRABHU, Anika   29:09
Thank you.
So in order to formalize the grants and the funding in the Australian system, the Australian leads of the applications that are deemed fundable will be invited by the MRFF or NHMRC to apply for funding to support the Australian based component of the trial. So the exact same applic.
And same costs that were uploaded into the NIHR system at Stage 2.
Will need to be re uploaded into Australia's sapphire system for a final.
So full details on this assessment and budget approval steps for any Australian component of the trial are available through the Australian Grant Opportunity guidelines.
So these guidelines are public now on Grant connect as a forecast grant opportunity and it is forecast and will remain so because this sapphire step will not be open until 2026.
And then the final outcomes, as Sarah mentioned will be.
Notified to UK and Australian joint leads of all applications in Q2 of 2026.
So the next slide just reiterates the timelines and the two stage process.
So it is critical that all applicants submit stage 1 application through the NIHR system by 23rd of July.
So 10:00 AM UK time and then as Sarah mentioned, the shortlisted applications make their way to a stage two full submission that's due by.
27th, 7th of November 2025, again at 10:00 AM UK time and then the formalisation of the Australian research component will happen through Sapphire in order one of 2026 final outcomes in Q2 2026. And as Sarah mentioned, the awards and.
Grant activity is estimated to start in quarter three or quarter 4 of 2026.
Thanks.

Sarah Puddicombe   31:10
So just thinking about submitting your stage 1 application as an Annika mentioned, it's going to be submitted via the Nhr realm system. We've put in a link on how to apply here.
Now when you submit, please do make sure that your guidance your application has followed all the guidance that you've met the eligibility. If you have concerns or questions about your eligibility, please do contact us.
We're here to answer questions.
Check the assessment criteria have been met.
Application and that you include all of the uploads, so you have some mandatory uploads which are a flow diagram, some references and as I mentioned briefly earlier details of your Australian team members and a declaration of any potential conflicts of interest.
And then there's an optional ability to upload some papers that you may have in press.
So in terms of support available for UK applicants, we would like to ensure that you think about approaching the research support service which provides free and confidential support to researchers, particularly for those who are based in England or have or who might have a project partner based in.
England.
For those researchers in the wider UK, we have dedicated support for Scotland, Northern Ireland and Wales. As I've listed here.
We also have the study support service, which can help researchers and the life sciences industry plan and deliver high quality research to time and target.
And really does support researches across the England in the NHS and the wider health and social care environment.
And we support this service for all studies through the research delivery network portfolio and that's regardless of your location, study type, size or research area.
And Anika, I think you're going to talk through the Australian support.

PRABHU, Anika   33:21
Thank you. So for Australian applicants, we strongly encourage you to speak to your institutions and their research administration offices as early as possible.
They can contact nhmr CS Research Help Centre for any general advice or specific queries about this grant opportunity. And as with all of our grant opportunities, please also consider utilising existing research infrastructure projects such as the National Collaborative Research Infrastructure Strategy or Nick Chris and certainly work.
Closely with your collaborators in the other country and access the resources available in the other countries as well. Thank you.

Sarah Puddicombe   34:03
So Andrew's going to now give us some hints and tips on planning for success in terms of of your application over to you, You're on mute, Andrew.

Andrew Farmer   34:24
So I'll try and go through these these tips reasonably quickly and just try and emphasize.
So perhaps at the end some some really set of overarching comments so.
Please sort of read the guidance, the funding guidance carefully there is.
The the NIHR web pages.
And the guidance for this are extremely thorough and they reflect the process that we go through.
So if you miss things out that are stressed in the guidance, it will be to your disadvantage.
I think perhaps one of the most important things is the evidence gap or the unmet need that's being addressed.
One of the sort of things about nhr research is that it is it is needs led with the science added to it.
And I think it's a.
Something that's worth bearing in mind we want to know. You know how this is going to benefit patients and the health services in both our countries and what the strategic.
What the strategic sort of framework is in within which that's being addressed, you know, is it a priority for our countries?
Each of the intervention arms does need to be justified.
You've already got two or three sentences, but one really.
It is really important to sort of say, well, why you know, is what's the evidence that this a important and B.
We don't have enough information already about that, and to have that sort of threaded throughout the application is incredibly helpful and other thing I said before, a coherent pipeline of interventions that can come behind that we've talked about phase two or phase three.
A note you know a question about why we're not having.
Seen this transition between those.
That's a real. You know, it's something that we've debated hugely.
But we have observed that in attempts to to do phase two to phase three research, the regulatory barriers at the moment are a huge problem there and sequencing that without huge delays has been a problem.
So I think for the moment, we don't want to get, we want to.
We want these to succeed and be as straightforward as possible, and I think that's something around the appropriate design to meet the identity identified needs and that that should be simple and straightforward.
More complex proposal, the less likely it is to be delivered.
Again.
As we've emphasized, it's really important their inclusive approaches to address inequities and maximise the benefit from from collaborative Australian UK studies. So that involves involving the community.
Trials if Charles don't involve the people who don't involve the people that might benefit from that research, they're not actually going to provide an answer.
That's relevant.
So incredibly important to have strong involvement, but also to ensure that there is wide recruitment of the right of the, you know, the people.
Be affected.
We're keen to build clinical trials, research capacity and expertise for early and mid career researchers. So thinking about that within your teams is really important.
It's a seven-year, you know, up to A7 year platform possibly beyond.
So to have a clear pipeline of.
Involving those early in the career researchers and how they can can be more involved going forward is again important.
Justify, deliverability and value for money.
And sustainability.
Support funding for additional future interventions? Is there another slide there?
OK.
Next slide. Here we go so.
This is just, again, to emphasise some of the things in in a bit more depth.
We've talked about a pipeline of interventions.
The statistics and data management needed for a cross country platform are hugely.
Can be hugely complex.
We're keen to see innovative adaptive designs and use of Bayesian analysis.
But again.
The focus of this needs to be on actually delivering information about important topics in an efficient way and.
We'd want to see those innovative designs and analysis plans to support not as an end in themselves.
Deliverability and value for money.
Again, hugely importance. We know from having funded.
Work funded multi centre trials.
Before from from the NHMRC Nhr collaboration and from from other trials as well, that there are issues around sponsorship which do need to be worked through very carefully.
And very important to to ensure that you get the best advice about that locally.
These things can be can be sorted.
But it's important to start addressing them very early and not something to be left down the line as a as a last last thing because it just delay hugely startup regulatory approvals again, especially around medical products, devices and investigation.
Medical products need to be thought about in advance.
Clinical trials, unit support or equivalent is hugely important, just the.
Existence of people experienced in delivering trials, but I think as we heard at the very beginning of this, the environment around international clinical trials around clinical trials generally is is changing with the World Health.
Organization push towards.
Efficient designs and a new model for for clinical trials and and we would want to see that not least because of its emphasis on including.
Previously.
Unincluded groups and and in delivering efficiencies in trial delivery and simplicity and plans for the future.
We've heard a bit about engaging commercial companies and other funders to.
Future arms of the study.
We are supportive of that in an open and transparent way.
I think I should leave it there, Sarah.
I'll leave you to add anything.
I haven't said already, but I think 3K message 3 clear messages.
Clearance clear strategic alignment to to health needs.
Showing that you could deliver it and deliver value for money is probably the things to that would really sort of bring this home to the funding plans.

Sarah Puddicombe   42:01
Thank you, Andrew.
And and I think if you do have questions and queries, we are here and I wanted to reiterate that. And equally I think to reiterate Andrew, that the importance of making sure that you've got good strong patient public and patient involvement and consideration of research inclusion.
If you have a proposal that you'd like some feedback from, then do we encourage you to do set it out in a pico summary so that you've got the sort of patients population, the intervention, the comparative and the outcome and then we can provide you some more support?
On that.
But if you are working around proof of concept, please do phase two platforms.
Please do site any sort of evidence that that intervention could work that you might have.
We really can provide you some sort of tailored feedback.
And equally, if you're working on phase three that you have some evacu evidence of efficacy of the interventions that you're proposing.
As I mentioned that those of you who go to committee will all get feedback, but if you're successful to move from stage 1 to stage two, then we do really encourage you to respond to the funding committee member feedback at Stage 1.
And at stage two, you will then have external reviewer feedback which you will be able to rebut.
But we will be expecting to see a clear rebuttal why and description of any changes.
Might make in response to that feedback, and should you disagree with the feedback, then for you to please explain that justification as to why you you wouldn't.
Listen to the particular aspects of feedback, but I think if it's from the committee, I think you do really need to to bear that in mind and I I can ask the others on the panel to reiterate that later.
So I think we've now concluded the main summary of the.
Sort of.
The the cool and the funding opportunity, as I mentioned, we are going to make the recording the slides available, we will have AQ and a session now and we'll then record those Q and as write them up and make sure that they're available to you and any that.
We haven't been able to answer.
We can also do that as well.
And please, I think a plea would be to if you have queries, please don't leave them until the last week of the submission deadline.
So please make sure that you've come to us early on.
We can help you if we have time.
And don't leave it to the last minute to submit your application.
There are quite often challenges in those last few hours as everyone jumps online, so we do encourage you to to try and submit as early as possible and contact us if you have any issues with submission.
I'm now going to open up to asking some of the questions that I can see have been submitted.
The first question was around the the phase two phase three platforms.
But I think Andrew, you very nicely already answered that.
Around the challenges of undertaking this sort of phase two to phase three platforms. So the next question is, is the funding for trials of therapies and treatments or are studies of new diagnostic technologies also in remit?
And I wonder, Andrew or John, would you would you like to comment on that?

Andrew Farmer   45:49
The money you get now.
Happy adding anything.

John Simpson   45:53
Thanks Andrew.
Yes, I think diagnostic interventions are within remit without any shadow of a doubt, but must still fulfil the criteria that have been described already, in particular for phase two trial. We absolutely expect for there to have been evidence of proof of concept and for any phase three trial.
Further, to have been clear evidence for.
Efficacy and these are quite prominent features when it comes to the assessment process.
So definitely in remit, but ensuring that they they capture those elements of, as I say, proof of concept in humans for.
Phase two and.
Proof of efficacy.
In in humans for phase three.
Thank you.

Sarah Puddicombe   46:44
Thank you.
There's another question here.
Would it be acceptable to propose a trial comparing a mixture of older, established clinical practice, but without good evidence of efficacy, effectiveness and safety?
Technologies with newer phase two stroke phase three interventions.
As long as they're either phase two or phase three.
I think that that would be acceptable.
Would anyone else like to add to that?
Sanji.

Andrew Farmer   47:23
So I agree.
It would be in remit, but just remember what's the purpose of the comparisons?
So at the older therapies standard of care.
And if there isn't evidence for them, well, that's OK. If they're being used. But, well, what are they being compared against?
So I think having the purpose of this, you know, at the end of this, what are we going to know that we didn't know before that's going to make a difference for patients.
So I think just really thinking through that.
So just sort of putting in a series of things to compare, some of which are in use and some of which are novel without a clear thought forward as to what difference that's going to make. It wouldn't have much impact on the panel. Thanks.

Sarah Puddicombe   48:11
Thank you.
The next question is in the eligibility requirement.
It states that new platform studies. Does this also include existing platform trials with new research questions or expanding to new patient populations or groups?
John, would you like to comment on that?

John Simpson   48:41
Yeah, I think we go back to the the thing we were saying before that that really we do expect.
A new application for new platforms in either the phase two or the phase three space.
I think that's probably the thing to, to stress again. I don't know if Andrew, if you want to make any other comment on that.

Andrew Farmer   49:00
Well, I mean, you know, we're obviously wanting to put a lot of money into this area to actually stimulate new things.
So you know, funding something that's already going probably wouldn't fulfill many of the things here about developing new capacity.
If there was a really solid argument around extending it into new areas, bringing in new people, developing new partnerships, and I think we would look at that. But I think just on the basis of well, it's already working. Can we have some you know can can we sort?
Of, you know, put further funding into that and add some more arms to it.
Wouldn't reflect the the overall strategic aims of this. Thanks.

Sarah Puddicombe   49:40
So there's a question here around confirming the time spent on non research activity is considered a career disruption.
This is usually considered relative to the opportunity with NHMRC and MRFF, so it does not affect your time post PhD like parental leave carers leave.
Can you confirm the time spent?
I'm just trying to get my head around quite what it's saying.
Is could.
Yes, I think.
What you're saying, what the question is asking is, is time spent on non research activity considered a career disruption?
And I believe yes, we are clear, Anika. That's true for the NHMRC and MRFF.

PRABHU, Anika   50:25
There is a specific definition of career disruption which will include in the FAQs afterwards, but I don't know if any other Australian colleagues want to jump up.
See cherise.

Cherie Atkinson   50:38
Yeah, I can just.

PRABHU, Anika   50:38
Come on board.

Cherie Atkinson   50:39
Yeah, yeah. We can quickly jump in.

Sarah Puddicombe   50:39
Terry.

Cherie Atkinson   50:42
So our guidelines will have a definition of what is considered a career disruption. So for example, if you've taken maternity leave or had you know, medical issues, that sort of thing, we can look at that and it counts towards your track record and your opportunities.
So when assessors are reviewing it, they can go whilst you've had your PhD awarded 10 years ago, you've really only had.
Five years of research opportunity because you've had, you know, time off from the research sector.

Sarah Puddicombe   51:16
Thank you.
Have we got Charlotte in the background, I believe?
I'll see her.
She might be having having a disruption, but I will make sure that in in the FAQ we we confirm that. But yes, I think we do look in a holistic way at career breaks for a number of reasons and then take that into account.
But we can give you more details in the FAQ when they when we send them round.
Please explain what you mean by an existing platform.
For example, can an existing platforms be built on in terms of learning and design, but applied to a different disease area or a different focus within the same?
Area.
Now I what I'm trying to work out is, is that you're taking the learning from one platform and then applying it to a different area and to a different approach.
John Andrew, do you? Is that how you're interpreting this question? Sorry.
Oh, Andrew cook.

Andrew Cook   52:27
That that seems to be two questions.
Clearly, if you've got experience with running a different platform, learn from it.
Use that to inform a new one.
You're designing what we're looking for here is something that involves a new set of patients, a new set of technologies. I'd say if you've currently got regulatory approval for it or funding for it, it's not new.

Sarah Puddicombe   52:48
Thank you.
Now those the only questions I can see there, but I think there are many more questions coming.
On here.
So there's a question here around the total of 5 million maximum for for the program and there's been limited scope to fund actual RC TS for evaluation of multiple interventions.
A requirement implicit in a platform approach is the intention to primarily fund the platform and get applicants to secure funding for specific interventions elsewhere.
I.
I believe that the what we said in terms of the funding is that there's a maximum limit of 5 million Australian dollars.
And that for the UK, we will pay on average an equivalent equivalent to that.
But there is no absolute limit.
I believe we've said that we would fund between 1:00 and 3:00 trials. Obviously, if you have an expensive study then.
As long as that's well justified, there's good consideration, I think then, as funders, well in terms of the UKI believe, we would, we would fund more.
In essence, do you have any comments I can see you nodding wildly there so.
Perhaps you'd like to come in?

Thomsen, Inesa   54:25
And I fully recognize and also recognize the potentially the cost might need to be slightly different in the UK and Australia.
So it's all about being pragmatic here, and the panels will consider that accordingly.

Sarah Puddicombe   54:40
Thank you.
Would anyone else like to come in?
OK.
Thank you.
I think we've had questions about existing platforms, which we've answered.
There's a question here around with long assessment times. Are the funders allowing for variations for the chief investigator, team or platform designs, noting that a lot can happen between now and the end of 2026?
So I can see John nodding.
John, did you want to come in and comment?

John Simpson   55:15
Yeah. Yeah, absolutely. Thank you.
I mean, given this as you say, it has a long gestation and there's a two stage process, I think it would be it would be wrong not to update your team as as is scientifically and trial wise required.
So I think changes over time of the application are absolutely allowed as as long as they are justified and in keeping with the evolution of the trial design.

Sarah Puddicombe   55:41
Thank you.
Slightly out of order now, but I can see one here that says. Can you explain how addressing the priority areas effects the assessment?
My understanding is that we have articulated some of our priority areas to you because those are shared priority areas.
You can still come in and suggest another unmet clinical need and if that's well justified, we would treat that in exactly the same way.
So I don't think there's any.
Ordering as long as they meet important priority areas and you can justify that. Obviously we we've indicated some of the shared areas of interest that we have, but we wouldn't preclude you from coming in with an application that was against anything else that had a really strong Rob.
Design and a strong pipeline of interventions that could be assessed.
Then I can see there's I understand the phase 2-3 transition is not in remit, but could the platform have some interventions work that work that are phase two and others that are phase three?
I must admit I've taken it that we were looking at either phase two alone or phase three alone, rather than a combination of of two different approaches.
Andrew, did you want to come in at that point?

Andrew Farmer   57:08
I mean, it's the same question that was raised earlier.
There are a number of theory.
Well, you know, there are a number of advantages of.
Allowing them to sort of stream together in terms of potentially pushing things through more quickly, however.
Our experience in funding sort of phase two to phase three transitions in the past.
And we still see the same problems.
Is that there are regulatory difficulties in actually pushing these through.
And that has, you know, I can think of at least one one occasion where where you know this dragged into two years of not being able to progress from today's due to stage 3.
So it's not that we're discouraging people thinking about that for the future and we'd love to do it, but we need to sort of get more experience in actually doing the straightforward phase two and phase three first.

Sarah Puddicombe   58:06
Thank you.
There's a there's a question here around building capacity and support for early career mid career researchers and I mentioned that there is a competitive entry requirement.
But the question here is, is that expected to happen after funding has been obtained?
So if you're successful and you, you're awarded the award through that, we would expect you then to be offering openly.
The opportunity to to undertake the early or mid career researcher training as part of of your.
So I hope that's clear.
Does is there anyone in the background who'd like to comment more on that?

John Simpson   58:46
Only Sarah, that it's a. It's. Oh, sorry, sorry, go ahead.

Charlotte Minter, NIHR   58:47
Yes, Sir, I can.

Sarah Puddicombe   58:47
OK.

Charlotte Minter, NIHR   58:51
Sorry, Sean.

Sarah Puddicombe   58:52
Charlotte, I couldn't see you, Charlotte.

Charlotte Minter, NIHR   58:52
No, I was just.
No, I was just going to say for those early early, mid career researcher post that you want to fund through this award.
They would need to be competitive.
Who would benefit them from the Nhr Academy membership?
They would need to be competitively recruited.
They would, we would ideally suggest that that is done once the contract is in place. Those positions can start at any point over that period of obviously the the platform and study as well.
But yeah, they would need to be competitively recruited once the contract is in place.
So it's an open competition.

Sarah Puddicombe   59:32
Lovely. Thank you.
So are the studies that are not focusing on the four identified areas likely to be competitive?
I think we've already answered that question.
If you're well justified, you're meeting an unmet clinical need, then we would consider you amongst everything else.
I'm confused about phase one study.
Can you explain please?
I'm not absolutely clear.

Virginia.F.J. Newcombe   1:00:01
What?

Sarah Puddicombe   1:00:01
Sure, what?
That questions getting at anyone help me there.
Phase One is this stage 2.
The Stage 1 assessment.
No, sorry if if.
Manateear you could add a little bit more.
We might be able to answer that question.
Can you give your guidance on inclusion of Australian Indigenous First Nations patient groups please?
Annika. Would that be you?

PRABHU, Anika   1:00:36
Yeah. So we have some resources that the MRFF and NHMRC that we can provide with the FAQs, but essentially.
One main thing that's quite important is that the.
Trial is patient, centred and designed in, or tries to involve, the First Nations community as much as possible.
Nhmrc also have a specific indigenous research excellence criteria.
Sheree, I don't know if you want to speak to that or we can include those resources.
The response?

Cherie Atkinson   1:01:09
Yeah, we can then.
Yeah, look, the the guidelines on the Australian side go into a little bit more detail under if I'm correct here. I've got the guidelines open up to Section 5. So I highly advise you to go and have a look at that. And as Anika mentioned, the NHMRC has.
A range of guidance to make sure that the research is conducted safe and respectful, and there are other useful resources as well that we could.
Definitely provide links to help.
With that aspect.

Sarah Puddicombe   1:01:42
Fantastic. That would be really helpful.
I can see that there's another question here asking for some examples or references of phase two or phase three platform trials that have been completed and that in our view are exemplary.
We have been collating some extra resources to share with the slide set that we send out with you, but we can add some examples to the FAQ.
I don't know that I want to put anyone on the spot.
Give you unless you've got one. One of those trials that you think we should be mentioning, but I think we can share those with you when we pass out the FAQs, can you give guidance on what to what extent it is necessary to specify the intervention arms I?
Is the view that the funding is supporting a trial?
Of N specific.
Interventions or is it OK to specify one or two intervention arms but leave others uncertain?
And I think what you're saying is, as long as you've got a couple of interventions that you absolutely know about and some that are coming online.
But may not be so certain that would be acceptable.
Do you agree?
Yes, I can see John nodding.

John Simpson   1:03:13
I think that I think that is, oh, sorry, I think that is acceptable. I think that is acceptable.

Sarah Puddicombe   1:03:14
So.
No. Carry on, John.

John Simpson   1:03:19
You can imagine that in the assessment, the more mature and the stronger justification for interventions the better.
And so I think in that setting, if you have one or two, it's it's fine, but you'll have to have a very strong.
Evidence of a pipeline that will is likely to have a robust evidence based way of adding further interventions in as required, I think.

Sarah Puddicombe   1:03:43
Thank you.
The next question are are you able to include in translational component IE a biomarker discovery for next generation of biomarker guided trial hypotheses and methodology eg a SWAT.
Andrew Cook, would you like to answer that question?

Andrew Cook   1:04:08
Candid swats. Yes, translational elements.
Yes, biomarker discovery, no.

Sarah Puddicombe   1:04:16
Thank you. Short and sweet.

Andrew Cook   1:04:21
John has something to add.

Sarah Puddicombe   1:04:22
Oh, John.

John Simpson   1:04:25
That's an absolutely perfect summary from Andrew.
The EMI.
The M&E Me stands for mechanism and it is justifiable in phase two studies to include an element that investigates the mechanism by which the intervention works in a phase two study.
But Andrew's response is right. Biomarker discovery is is out and the mechanistic component must be mechanism rather than you know rather observational favoured work.

Sarah Puddicombe   1:04:55
And I think in our guidance we have mentioned, that's what's what's what's our are able to be included.
So the next one is. Can you clarify what you mean by existing platforms?
I think we've done that.
David and done that one.
Can anyone see a question that I have missed that perhaps?
Needs addressing.
Just go.

Andrew Cook   1:05:30
There's one on can investigators be on more than one application?
I don't think we've done that.
I think the I think the answer is yes, but not as chief investigator. So you can only lead one, but it's appropriate to be on more than one.

Sarah Puddicombe   1:05:34
Oh, I didn't see that one.
Yes.
Play. Thank you.
Let's check what new posts have come in.
OK.
So there's a just now we've just had one which says please can you clarify what it is?
What's meant by convincing evidence of pipeline for interventions?
Andrew.

Andrew Farmer   1:06:09
Sorry, I was just coming in on the previous one.
So yet you can't have an update on. You can have an applicant on on more than one application, but we have had instances in the past where reserve teams have not been aware that the person was on multiple applications.

Sarah Puddicombe   1:06:12
Oh, pard me.

Andrew Farmer   1:06:25
So I think I would add to to to what we said just then so they can, but it needs to be strongly justified.
I mean, have they got?
A unique skill that means they they're the only person who can go on each application.
And there has to be transparency that each of the research teams know that and have got and are happy with arrangements for.
Not inadvertently sharing information about each other's applications.
I think that that could well cause problems and you know we have. You know, we've stepped, stepped away from it.
We've stepped away from applications where that's happened in the past, but you really don't want to be drawn into a discussion about, you know, who knows what and who's been taking information from other other people's applications so.
Just to you know, it's not straightforward if you want to be on multiple applications, and I'd suggest asking for further advice about that. Thank you.

Sarah Puddicombe   1:07:26
So there is still this question around the convincing evidence of a pipeline.
Would would someone like to comment on that?

John Simpson   1:07:37
I'll happily take that, Sarah.
I think it comes down to two things.
Again, I'm sorry to keep banging this drum, but first please two that there is a previous proof of concept for phase three. That is, previous evidence of efficacy.
And in a human setting.
And secondly that your pipeline is mature that that you have a system by which if you have two candidates and you're proposing 1/3, it looks convincing to the assessment panel that there is a system in place to bring those products through.
In a timely and scientifically justified way.

Sarah Puddicombe   1:08:15
Thank you, John. Nice and clear.
There's a question around rare non listed diseases being a priority or needs to have a significant population impact.
Would anyone particularly like to comment on rare diseases?

John Simpson   1:08:39
I guess rare diseases are are something would be very interested in seeing I I think platform trials lend themselves to the assessment of rare diseases in a way that more traditional designs can't.
So they're absolutely in remit and would be judged against any other application in the same way.

Sarah Puddicombe   1:09:00
Hint.
Then we have a definition.
I think someone's asking what the definition for the early career mid career researchers are.
We have already just given that in the webinar.
It's it's fairly similar to the NHMRC definition of five years for an early career and five to 10 years for a mid career.
If feed funding is obtained for the project from other grant or philanthropic sources during the application process to initiate aspects.
Of the program, will this be viewed as a favourable leverage or is it no longer considered a new program? If there is other funding? If seed funding is obtained for the project from other philanthropic sources during the application process?
Genuinely, Andrew Cook, would you like to comment on that?

Andrew Cook   1:10:09
So this is a charity, for example, pays for some development work. I think you need to tell AI. Don't think it would weight committee decisions either way, but I don't know who's on the committee yet.
So, or we're going to brief them, so can't exactly answer that.
I think you've got a Clear History of the project being put together specifically for this call. If a charity, for example, chooses today to bid on Monday for you to work on it, I think that would be fine.
That's rather like if your university gave you a.
Money to work on it.
So so you can demonstrate a Clear History.
It's it's not established.
You don't currently have regulation approval.
Someone's paid for you to put together the initial work, put together a protocol, maybe do some PPI activity before you put the proposal in.
I mean, that'll be fine.
The mere fact of getting the money wouldn't help. What you do with it could be very constructive.

Sarah Puddicombe   1:11:04
Thank you.
So in Australia, the NHMRC and MRFF have historically favoured grants that support minority communities, noting that veterans are often not prioritised. Will veteran communities be considered equally?
I believe so. I think sorry, Cherry.

Cherie Atkinson   1:11:26
Yeah, yeah, I can jump in, so.
There's no priority populations listed under this grant call, so it's not specific to First Nations or specific to other populations.
And so there's no eligibility criteria for this call as well.
So for example, it must address First Nations or you know other populations.
So all applications will be assessed under the criteria.

Sarah Puddicombe   1:11:56
Lovely. Thank you.
Then there's a question here about.
Can. Well, there's couple here.
Is there a preference for large well powered cohorts over trials using small cohorts within an innovative endpoints?
Country.

Andrew Farmer   1:12:26
I think that rather comes down to what innovative endpoints means.
I think endpoints need to either for a phase two trial sort of provide some evidence that you know there is an effect, there's efficacy that something is happening that could translate into they should benefit or for a phase three trial that there is an outcome that.
That is patient centered and involves improvement. So the type of trial about that, that sort of comment talks about is is an important sort of trial, but it tends to be at an earlier phase of the research process.
So I it would obviously come down to a funding battle looking at that application and trying to make a judgement against what else was in front of it.
So I think that would need some careful thought through, but you know we're not in it.
You know, we're not necessarily just after big, you know, sort of large numbers of people with this. And it may be that a really thoughtful application can, you know, provide evidence with smaller numbers of people. And that's absolutely fine.
I think it's just that, you know, with the sort of comment about innovative endpoints, I think that would need some some careful thought as to as to whether.
You know, innovative is also.
Able to sort of give the you know sufficient.
Information to to shift clinical and science practice.
I hope that's helpful, John.
Probably got some some thoughts on that as well.

John Simpson   1:14:02
That's perfect.
So Many thanks.

Sarah Puddicombe   1:14:05
Thank you.
I'm now trying to see if I've just lost the Q&A one second.
There's another question here around CTU investigators can be Co applicants across multiple applications. I believe we just said exactly that, that if you need to lead, the chief investigator cannot be on more than one application. But other members of the team might be.
But Andrew gave some very careful guidance on on some of the considerations that might be needed to be thought of.
In that respect.
There's a question then around.
Umm.
Do you have a rule about Charity Co funding?
I'm less well clear on Charity Co funding for Australia. I mean in this in relation to this call, I think we're looking at both of the Australia and the UK funding the majority, but in essence, do you have a view about Charity Co funding?

Thomsen, Inesa   1:15:16
So if the question is in terms of leveraging additional funding from other sources, including charitable funding, then absolutely.

Sarah Puddicombe   1:15:26
Lovely. Thank you.
Are trials focusing on lifestyle interventions rather than drugs and devices for the management of disease in remit?
Andrea cook.

Andrew Cook   1:15:42
I'd say yes, provided you control as a likely sort of health benefits or plausible health benefit. We from an nhr point of view, we take a very broad view of what an appropriate intervention is to assess.
I tend to be quite broad in terms of, you know, something that's under the conscious control of a human.
To way more than just drugs and and devices. But tell us why it's important. Tell us why.
World should care about knowing the answer to your question.

Sarah Puddicombe   1:16:18
Make sure there's a pipeline of interventions that, that, that are coherent and that make sense.

Andrew Cook   1:16:20
Make sure there's a pipeline.

Sarah Puddicombe   1:16:23
Andrew, would you like to add something?

Andrew Farmer   1:16:26
Just very briefly, I think.
Yes, of course there would be a remit, but it's challenging with lifestyle interventions to to come up with something that that actually does fit a platform trial. You've got to have something that is similar enough as an intervention, but you know.
Could could tackle a different aspect of it and send you know the same population, so you of you know we we have these for our large platform call.
And it was often a series of very different event interventions and a series of very different people. And it was hard to see what the efficiencies being gained from a platform approach were. So just a note of caution that it's not entirely straightforward to do that. Thank you.

Sarah Puddicombe   1:17:13
Thank you.
There's another question then around seed funding.
If seed funding lets you get started, recruit 20 pilot patients meeting good feasibility goals, but also perhaps a significant quota of patients.
A rare disease trial.
I when is? Is it an existing platform versus development for this call?
It's very tricky to.
Someone else had more time to digest that question.

Andrew Cook   1:17:50
And I think this might go back to what I said earlier. If you got patience or regulatory approval, it's not new and that feel, I mean a committee will take a view, but that feels rather developed and you wonder why do you need money from us if you?
Got to the point of recruiting a significant number of patients.

Sarah Puddicombe   1:18:08
Thank you, MJ.

Andrew Cook   1:18:09
OK.

Sarah Puddicombe   1:18:12
Are there other?
I'm just checking to see what other new things.
So there is a question here about will platform trials that address rare but critically important outcomes such as perinatal mortality, and therefore include low and middle income countries?
Beyond UK and Australia be at a disadvantage in this call.
It's beyond be at a disadvantage.
If you're including countries outside the UK and Australia, you will need to find other sources of funding to support those.
Andrew, I can see you've put your hand up.

Andrew Cook   1:18:58
I'd also suggest there'd be a massive disadvantage, because if you're relying on recruiting large numbers of patients for lower middle income countries for an event like perinatal mortality, it's very unlikely that your findings will be relevant to the UK or Australia.
Because the context in which you'd be recruiting most of your patients would be clinically so different.

Sarah Puddicombe   1:19:14
OK.
And I think it's worth stating that the nhr at least do have a separate official development assistance funding that will really support work occurring in low middle income countries. And that might be a more appropriate funding route for those studies.
Umm.
There's another question around.
Could you comment on registered adult medicine where there's no pediatric evidence?
Can anyone answer that one?

Andrew Cook   1:20:04
The comment is it's common if if you've got a good reason for assessing it in children, and it makes sense in terms of pipeline and everything else that we've been talking about, it would be reasonable to submit a proposal to evaluate a a medicine, established adults without EV.
In children, but you need to meet the same criteria in terms of proof of concept and similar that we've been talking about for anything else.

Sarah Puddicombe   1:20:30
There's a question here about looking for the platform to build in assessments of cost and clinical effectiveness with health economics. I would said absolutely yes, please.
Anyone else like to add anything?

Andrew Cook   1:20:45
Absolutely. For the phase three.

Sarah Puddicombe   1:20:48
Yes.

Andrew Cook   1:20:49
Possibly not for the phase two.

Sarah Puddicombe   1:20:55
Are there any new ones?
So what is the definition of neurodegenerative diseases as one of the priority areas?
Will neuro inflammatory diseases, which have a degenerative component such as MSB included?
You can see John nodding.
Would you like to add anything more, John, to that?

John Simpson   1:21:19
Yes. Is it.
Is the short answer.
I mean, as we've said before, I think any, any disease as well justified as having a clinically unmet need will be considered carefully in this call. I think the priority areas that have been highlighted I think is largely to that we have a good stimulus for applications from.
Those areas, but other other diseases are absolutely required as you see.
Degenerative Ms. could fall within the generation on euro inflammatory.
Both very, very welcome and applications would be considered warmly.

Sarah Puddicombe   1:21:58
Thank you. I think it looks very much like we're.
Are there any questions anyone else has seen that I have missed?
Do shout because I I think I've covered them all.
But if we have missed any, we can always come back.
Open it. There's another post that.

Gemma Bashevoy   1:22:21
I'm trying to find them and post them again for you.

Sarah Puddicombe   1:22:24
Thank you.
The definition I think we've answered that one.
We've got only a few minutes left. Let me just check if if there's an established platform examining standard of care and getting networks set up and we want to start an intervention trial phase three.
So effectively a new trial, but built on to the existing platform.
Umm.
And to you.

Andrew Cook   1:23:05
Well, you need to explain what's going on, but from the text there that looks like it's not a new platform study.
So no.
We're not in this to fund additional arms for for platform research that currently exists.
There are. There are other sources for that funding in both countries, but this call isn't it?
I'm sure if Sarah remains perplexed or is frozen.

Debbie Willis   1:23:55
I think Sarah's probably frozen at this point, so.
Let me see what's coming in. The one of the questions I can see is, is dementia, a degenerative disease?
But there's no other real question around that, so.

John Simpson   1:24:17
Certainly eligible in this call.

Debbie Willis   1:24:20
Yes.

Sarah Puddicombe   1:24:23
Are there other new questions?
I think it looks like we've answered the majority of them.
Debbie, do you agree?

Debbie Willis   1:24:32
Yes, I think so, Sarah. Yeah.

Sarah Puddicombe   1:24:35
Thank you.
So apologies, I think I was glitching out a bit then so.
I would just like to 2nd.
I think that we can probably wrap up.
Now, but I was just going to share the last slide and say.
Thank you very much.
We we've we'll be wrapping up and writing up the FA QS.
As we mentioned, we'd like to wish you the very best of luck with your applications and thank you for such tremendous interest today and for those of you across Australia for joining late into your evenings and showing dedication and interest so that we are very, very pleased about.
This collaboration, and we're really looking forward to to having some good strong bids from you all.
If you've got questions, please please do e-mail our international applications e-mail.
As I mentioned, we'll share the slides.
There are more guidance and there will be more links to further advice and support based on some of your questions today.
And do please obviously refer to the advertised grant guidance both from NHR and from.
Australia, and I think Australian colleagues, that you do have a help.
Question help.
E-mail here as well, so that if there are specific Australian questions that you really just need to have, you know that dedicated support from obviously please please don't.
Don't hesitate to contact the help. The helpline there.
So thank you so much everyone for joining.
Thank you to the panel.
Thank you so much for for all of your support today, and I do hope that.
You have a very successful applications and we look forward to hearing from you.
Very shortly.
Thank you very much everyone.
Thank you.